强生COVID-19疫苗Ad26.COV2.S获得FDA专家组认可,有望成为美国批准的第三种疫苗

2021-02-27 Allan MedSci原创

近日,FDA咨询委员会一致投票赞成强生公司的单剂量COVID-19候选疫苗Ad26.COV2.S获得紧急使用授权(EUA),以供18岁以上的人群使用。

近日,FDA咨询委员会一致投票赞成强生公司的单剂量COVID-19候选疫苗Ad26.COV2.S获得紧急使用授权(EUA),以供18岁以上的人群使用。在FDA发布简报文件几天后,专家组就对此表示支持。在FDA的简报文件中,机构审查员表示,该疫苗在临床试验中似乎是安全的,并且可以抵抗SARS-CoV-2感染,并且在各种SARS-CoV-2变体中都具有功效。

强生公司疫苗研究全球负责人Johan Van Hoof表示:“如果获得授权,我们的候选疫苗将在全球抗击COVID-19的努力中发挥关键作用”。

Ad26.COV2.S有可能成为继辉瑞/BioNTech的BNT162b2和Moderna的mRNA-1273之后的第三种获得EUA的冠状病毒疫苗。前两者都使用mRNA进行工作,并已证明对症状性疾病的功效约为95%。强生公司的备案文件得到了关键性III期ENSEMBLE试验的数据支持。ENSEMBLE试验显示,Ad26.COV2.S预防接种后四周对预防中度至重度COVID-19的总体有效率为66%。

 

原始出处:

https://www.firstwordpharma.com/node/1804506?tsid=4

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    2021-03-01 科研科研科研

    强生的新冠疫苗获得FDA专家组认可

    0

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